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What Bayer's Qlaira Application May Reveal About Yaz Clot Risks

Bayer's FDA application for yet another new contraceptive pill, Qlaira, is interesting for a couple of reasons: What it says about the financial dependency of Bayer on its contraception portfolio and what it might say in terms of patient safety.

Bayer makes $443 million a quarter on its pills, they are its top revenue driver. But a U.S. judge recently invalidated the patent on Yasmin. To replace revenue lost to generic competition on Yasmin, Bayer must come up with a new patentable, branded product.

Thus Qlaira is less an advance in women's health than it is an advance in the legal health of Bayer's contraception portfolio. According to Bayer, Qlaira features this new difference:

Over the past 50 years, many new progestins have been developed for use in oral contraceptives, but the estrogen component remained the same - ethinylestradiol.

The new oral contraceptive contains the combination of estradiol valerate - which is immediately metabolized to estradiol, equivalent to the estrogen as produced by a woman's ovaries - with the progestin dienogest in a unique dosing regimen.

Bayer doesn't say whether the new combination will be safer than older pills, some of which have a history of inducing fatal blood clots in women. It merely says that Qlaira will deliver the "the right levels at the right time." (Side note: Reuters seems to have bought the notion that Qlaira is safer because it puts "less of a strain on the liver"; Bayer's own press releases don't say that.)

That begs an uncomfortable question about Bayer's other pills, Yaz, Yasmin and Yasminelle. Are they delivering the "wrong" doses by comparison? And is there anything wrong with ethinylestradiol, which as you can see from this logo, is the estrogen ingredient in Yaz?

The question is a crucial one because some plaintiffs' lawyers believe that the Yaz's progestin, drospirenone, might be at fault for creating clots because it has never been combined with ethinylestradiol in the U.S. before.

Inevitably, one of these pills will forge a better safety record than the others. That will raise a further question -- if one brand in Bayer's portfolio is demonstrably safer than the others, why should Bayer be allowed to market the less-safe ones in the same way as the safe ones?

It's a question BNET has previously raised about Johnson & Johnson's contraceptive patch, Ortho Evra. The product caused so many fatal clots in patients that J&J stopped promoting it, and yet it remains on the market as if there were nothing wrong with it.

Image: Qlaira logo.